Tokyo, June 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061999) titled 'Longitudinal assessment of CircuLAting Minimal residual disease in advanced non-small cell lung cancer receiving immune-checkPoint inhibitors: a prospective observational study [CLAMP] (WJOG23325L)' on June 26.

Study Type: Observational

Primary Sponsor: Institute - West Japan Oncology Group

Condition: Condition - Advanced NSCLC Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the association between the detection status of minimal residual disease (MRD) using Myriad's tumor-informed assay and prognosis in patients with advanced or recurrent non-small cell lung cancer (NSCLC) scheduled to receive immune checkpoint inhibitors (ICIs). Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - - Patients with pathologically confirmed non-small cell lung cancer (NSCLC) regardless of PD-L1 expression level - Absence of actionable driver mutations targetable in the first-line setting, or unknown driver mutation status - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Patients with stage III or IV disease ineligible for curative treatment (surgical resection or definitive radiotherapy), or those with recurrence after surgery or radiotherapy - No prior systemic therapy for advanced/recurrent disease - Scheduled to initiate ICI therapy within 4 weeks of registration (initiation on the same day of the week 4 weeks later is acceptable) - Deemed capable of providing tissue and blood samples for MRD testing by the physician - Patients with evaluable lesions according to RECIST version 1.1 - Aged 18 years or older at the time of informed consent - Capable of understanding the study procedures and providing written informed consent personally Key exclusion criteria - - Patients deemed unsuitable for study participation by the principal investigator or sub-investigator. Target Size - 250

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 24 Day Anticipated trial start date - 2026 Year 10 Month 26 Day Last follow-up date - 2030 Year 10 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070587

Disclaimer: Curated by HT Syndication.